Condition category
Not Applicable
Date applied
20/02/2012
Date assigned
20/02/2012
Last edited
27/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We believe that an increased intensity of physiotherapy, including an individualised structured exercise programme, will be beneficial for critically ill patients. To assess this, we will compare their physical quality of life on Critical Care discharge, and at three and six months following initial recruitment to the study. We will also look at changes in participants' mental health, and at the economic costs of the interventions. This study aims to compare two intensities of physiotherapy in critically ill patients. 308 participants will be randomised to two groups.

Who can participate?
Participants will be adults over 18 years of age, who are critically ill surgical or medical patients, and have been ventilated for between 48 and 72 hours.

What does the study involve?
Group 1 (control group) will receive usual physical rehabilitation therapy (Monday to Friday), including a once-daily functional retraining session. Group 2 (intervention group) will receive a more intensive physical rehabilitation therapy, including at least one functional retraining session per day (Monday to Friday), and an individualised structured exercise programme.

What are the possible benefits and risks of participating?
The possible benefits of participating are that if additional physiotherapy is shown to be beneficial to Critical Care patients, research participants will also benefit. This could be shown as improvements to physical function, longer-term health, exercise capacity and overall quality of life. During physiotherapy sessions, research participants will be monitored closely, and if any specific events occur, the session will be stopped. Research participants are patients who are already critically ill, and so additional precautions will be taken to ensure that the risks of participating are minimised.

Where is the study run from?
The study is run from The Newcastle upon Tyne Hospitals NHS Foundation Trust (UK).

When is the study starting and how long is it expected to run for?
The study opened to recruitment in January 2012, and is expected to run to June 2015.

Who is funding the study?
The study is funded by the National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) funding stream.

Who is the main contact?
Miss Gillian Watson
gillian.watson@ncl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Gillian Watson

ORCID ID

Contact details

Newcastle Clinical Trials Unit
Institute of Health & Society
Newcastle University
4th Floor
William Leech Building
Medical School
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom
+44 (0)191 222 8813
gillian.watson@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11389

Study information

Scientific title

A randomised controlled trial of intensive versus standard physical rehabilitation therapy in the critically ill: Extra Physiotherapy In Critical Care

Acronym

EPICC

Study hypothesis

This study aims to compare two intensities of physiotherapy in critically ill patients. We believe that an increased intensity of physiotherapy, including an individualised structured exercise programme, will be beneficial for critically ill patients. To assess this, we will compare their physical quality of life on Critical Care discharge, and at three and six months following initial recruitment to the study. We will also look at changes in participants' mental health, and at the economic costs of the interventions.

More details can be found at http://england.ukcrn.org.uk/StudyDetail.aspx?StudyID=11389

On 26/02/2015 the overall trial end date was changed from 03/07/2014 to 04/06/2015.

Ethics approval

South Central - Southampton B Research Ethics Committee, first MREC approval date 20/07/2011, ref: 11/NE/0206

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please contact gillian.watson@ncl.ac.uk to request a patient information sheet

Condition

Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Critical Care

Intervention

Group 1 (control group) will receive usual physical rehabilitation therapy (Monday to Friday), including a once-daily functional retraining session.

Group 2 (intervention group) will receive a more intensive physical rehabilitation therapy, including at least one functional retraining session per day (Monday to Friday), and an individualised structured exercise programme.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Physical QoL; Timepoint(s): Six months

Secondary outcome measures

Changes in mental health; Timepoint(s): Six months; Economic costs of intervention; Timepoint(s): Six months

Overall trial start date

16/01/2012

Overall trial end date

04/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participant has provided written informed consent, or their Personal Consultee has provided a signed Personal Consultee Declaration Form, for participation in the study, prior to any study specific procedures taking place
2. Medical and surgical patients (surgical patients are those admitted to ICU as a direct consequence of an operative procedure, or as a consequence of that procedure. All other patients are termed medical)
3. Age 18 years or over
4. Invasive or noninvasive ventilation for more than 48 hours
Target Gender: Male & Female ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 308; UK Sample Size: 308

Participant exclusion criteria

1. Invasive or non-invasive ventilation for more than 72 hours
2. Under 18 years
3. Patients receiving end-of-life care
4. Patients not expected to survive for more than 48 hours after enrolment
5. Acute brain injury
6. Acute spinal cord injury
7. Spinal surgery
8. Brain surgery
9. Multiple trauma
10. Burns
11. Rapidly progressive neuromuscular disease
12. Enrolment in another clinical trial
13. Post-cardiac arrest

Recruitment start date

16/01/2012

Recruitment end date

04/12/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newcastle Clinical Trials Unit
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Wolfson Unit of Clinical Pharmacology
Institute of Cellular Medicine
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit Programme (RfPB)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26009576

Publication citations

Additional files

Editorial Notes